Chapter III
CONDITIONS FOR AND ORDER OF RECEIVING MEDICINE REGISTRATION DOSSIERS SUBJECT TO DATA CONFIDENTIALITY KEEPING REQUESTS
Article 7. Conditions for receiving medicine registration dossiers subject to data confidentiality keeping requests
1. Apart from satisfying the general requirements on dossiers specified in the Circular on medicine registration, a medicine registration dossier subject to a data confidentiality keeping request must also contain at least the following documents:
a/ An application for medicine registration, made according to a set form provided in the Circular on medicine registration (not printed herein), in which the medicine-registering establishment shall express its data confidentiality keeping request by ticking in an appropriate box for such request and enumerate documents showing data requested to be kept confidential;
b/ Documents showing data requested to be kept confidential, which must be presented as clinical reports as prescribed in the Circular on medicine registration.
2. All the above documents must be appended with a "confidential" stamp, enveloped in a separate package, which is sealed and appended with a "confidential" stamp.
Article 8. Order of receiving medicine registration dossiers subject to data confidentiality keeping requests
A medicine registration dossier subject to a data confidentiality keeping request shall be received by the Vietnam Drug Administration in the following order:
1. Identifying contents of data requested to be kept confidential indicated in the medicine registration dossier under Clause 1, Article 7 of this Circular.
2. Checking the appearance of the confidential document package before breaking the seal and checking the format of documents contained therein under Point b. Clause 1, Article 7 of this Circular.
3. Comparing documents contained in the confidential document package against documents listed in the data confidentiality keeping request.
4. Recording the data confidentiality keeping request in the register of received dossiers and dossier receipts, and at the same time re-sealing the confidential document package, for dossiers satisfying the conditions specified in Article 7 of this Circular. If medicine registration dossiers subject to data confidentiality keeping requests fail to satisfy the conditions specified in Article 7 of this Circular, the Vietnam Drug Administration shall receive only medicine registration dossiers of registering establishments that withdraw their data confidentiality keeping requests.
Tìm kiếm
Thông tư 05/2010/TT-BYT hướng dẫn bảo mật dữ liệu thử nghiệm trong đăng ký thuốc do Bộ Y tế ban hành (Bản Word)